Assignment task: Why do you think a Chief Compliance Officer role was created?
During the 1950-1960 period, healthcare professionals prescribed a relatively new drug to women with terrible morning sickness. This drug was Thalidomide, which harmed the lives of many. Mothers who took this drug while pregnant would commonly give birth to disabled children (Kim & Scialli, 2011).
In 1979-1986 Pfizer had a new heart valve on the market, which led to the death of 300 patients (Tampa Bay Times, 2005).
In 1985-1998 Hoechst Marion Roussel was marketing Terfenadine, an antihistamine that resulted in fatal heart problems (Saleh, 2020).
The government has put regulations in place to avoid episodes like the above. These regulations require specific materials and data to be provided upon application to go to market and while the product is being sold.
Previously, the number of regulations was minimal, starting with the Pure Drug and Cosmetic Act of 1906. Today the number of regulations a company must abide by has substantially increased in quantity and complexity (Dunne, Shannon, Dunne, & Cullen, 2013). This advent of change has placed an enormous burden on companies to avoid wasting time and money due to non-compliance. The Chief Compliance Officer role was formed to address this need.
Compliance is not only for the public's safety, but it helps a company build a loyalty base of healthcare professionals and patients. In 2016, only 28% of those polled viewed the pharmaceutical industry favorably. The federal government was the only business sector rated worse (Saad, 2016). Drug safety controversies are one of the reasons for the public feeling this way (Silverman, 2016). With a strong CCO and strict adherence to regulations, the pharma industry could potentially recover their image that is if it is not already too soiled to be cleaned.
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